Laparoscopic fascial closure system

ABSTRACT

A tissue closure device to assist in retrieving a suture during a suturing procedure, the device including an elongated body having a proximal end, a distal end, and a lumen extending axially through the elongated body. The device further including an actuator rod at least partially extending through the lumen of the elongated body to actuate a plurality of wings and a plurality of shields attached to a distal end of the elongated body. The elongated body including at least one needle guide lumen with an opening an exit, the at least one needle guide lumen traversing the elongated body at an angle with respect to a central axis of the elongated body to guide a suture grasper to an enclosed suture retrieval cavity.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation of U.S. patent applicationSer. No. 15/401,173, filed Jan. 9, 2017, which is a continuation of U.S.patent application Ser. No. 14/564,331, filed Dec. 9, 2014, which claimspriority to U.S. Provisional Patent Application No. 61/913,910, filedDec. 9, 2013, the disclosures of which are incorporated herein byreference in their entireties.

FIELD OF THE INVENTION

The present disclosure relates to tissue closure devices, and moreparticularly to a laparoscopic fascial closure system that includes atemplate and a sliding suture retrieving needle for use during anintra-abdominal suturing procedure or the suturing of a puncture woundgenerated by a surgical trocar or other puncturing devices.

BACKGROUND

Minimally invasive methods for conducting surgery on internal organs,tissues, ligaments and bones use extremely small instruments such ascatheters, laparoscopes, and the like. The instruments are introducedusing very small incisions, for example on the order of 5 mm to 18 mm indiameter, into which a trocar or other introducing device is placed. Thetrocars may have a diameter, for example, between 3 mm and 30 mm, withthe smaller trocars leaving the opening substantially unchanged. Thelarger trocars may enlarge the opening. The trocars provide a reliableand fixed opening for introducing and removing various surgicalinstruments, viewing devices and other instruments used during thesurgical procedure.

While the incisions and the trocar opening are quite small bytraditional surgical standards, they still require closure aftercompleting the surgical procedure. Surgical closure reduces thepossibility of post-surgical infection, post-surgical herniation (forexample in abdominal surgeries), subsequent bleeding or other effects.Closure can be accomplished either through manual suturing or suturinginstruments used to complete the closure. In either case, suturing ismade difficult by the small opening size, for example not only formanipulating the suture but also for visualizing the procedure. Closureis also made more difficult by the need to suture the subcutaneoustissue, for example fascial layers, separate from closure of theoverlying skin, and doing so through a very small opening in the skinwhile also avoiding possible injury or damage to the internal organsduring such a procedure.

Conventional closure techniques such as those for closing openings inthe abdominal wall pass sutures through the abdominal wall tissue adistance from the original trocar incision. One or more sutures are thentied off to close the subcutaneous layer followed by suitable closure ofthe skin layer. It has been noted that the distance of the suturelocation from the original incision opening is important in order tosecure a suitable amount of abdominal wall tissue for forming a reliableclosure. If the distance is too small, the closure may not be enough toreliably close the opening without later complications.

Tissue closure devices, for example laparoscopic port closure devices,may be introduced into the opening after removal of the trocar device tomake easier the suturing of the trocar opening. Various methods andstructures may help in closing the opening, but may require asignificant number of steps for completing the closure. Some devices mayrequire a significant amount of manual care in suturing the opening andtying off the suture, as well as close visualization for accomplishingthe closure. Additionally, some devices have a significant number ofcomponents or special devices in order to accomplish the closure, orthey may not provide consistent and reliable results even under normaloperating circumstances.

This disclosure relates to tissue closure devices, including surgicalsuturing devices as well as such devices that can be used forintra-abdominal suturing and suturing of puncture wounds generated bysurgical trocars and other puncturing devices.

SUMMARY

A laparoscopic fascial closure system may provide a suture preloaded ona closure template for insertion into a body cavity that may be usedwith a suture grasper retriever to easily capture a portion of thesuture with the template disposed within the body cavity and thenfacilitating free movement or sliding of the suture at or within thedevice tip during retraction of the device from the body cavity.

According to one exemplary embodiment, a tissue closure device includesan elongated body defining a central longitudinal axis and including aproximal end, a distal end, and a lumen extending axially through theelongated body. The tissue closure device further includes an actuatorrod at least partially extending through the lumen of the elongatedbody. A distal portion of the elongated body is pivotally connected to aplurality of wings, which are pivotally connected to a plurality ofshields. The plurality of shields are pivotally connected to a distaltip portion of the device, the distal tip portion being attached to adistal end of the actuator rod. The plurality of wings each include anopening to allow passage into a suture retrieval space defined betweenone each of the plurality of wings and plurality of shields when saidwings and shield are extended away from the elongated body in a deployedposition of the device.

According to one aspect, the opening is a round or open shape.

According to one aspect, each of the plurality of shields is connectedto a corresponding one of the plurality of wings via living hinges.

According to one aspect, the plurality of shields and the plurality ofwings are pivotally retractable to be parallel to the elongated body asthe actuator rod is moved in a distal direction with respect to theelongated body.

According to one aspect, the plurality of shields and the plurality ofwings extend at angles laterally away from the central longitudinal axisas the actuator rod is moved in a proximal direction with respect to theelongated body, in the deployed position.

According to one aspect, the elongated body further includes a pluralityof suture runner guides to control a location of a suture loaded ontothe device, each suture runner guide disposed at a predeterminedposition distal to an inner surface of each of the plurality of wings.

According to one aspect, the location aligns the suture in thepredetermined position to allow a suture grasper to orthogonallyintersect the suture, when said grasper is inserted into the sutureretrieval space, after passing through the at least one needle guidelumen.

According to one aspect, the plurality of shields prevent inadvertentneedle perforation of organs, vessels, or other tissues in the deployedposition.

According to one aspect, a proximal portion of the elongated bodyincludes a suture cleat for stabilizing or holding a suture taut.

According to one exemplary embodiment, a tissue closure system includesa suture grasper, a tissue closure template, the template including anelongated body defining a central longitudinal axis and having aproximal end, a distal end, a lumen extending axially through theelongated body, an actuator rod at least partially extending through thelumen of the elongated body, and at least one needle guide lumentraversing the elongated body at an angle with respect to a central axisof the elongated body. A distal portion of the elongated body ispivotally connected to a plurality of wings, which are pivotallyconnected to a plurality of shields, and the plurality of wings and theplurality of shields are operable to extend laterally away from theelongated body, in a deployed position, as the actuator rod is moved ina proximal direction with respect to the elongated body. The pluralityof wings each include an opening to allow passage into a sutureretrieval space defined between the one each of the plurality of wingsand plurality of shields when extended away from the elongated body inthe deployed position.

According to one aspect, a distal end of the suture grasper isinsertable through the at least one needle guide lumen and through theopening of the plurality of wings while the plurality of shields areextended laterally away from the elongated body in the deployedposition.

According to one aspect, the plurality of shields, in the deployedposition, prevent inadvertent needle perforation of organs, vessels, orother tissues by the suture grasper as the suture grasper is insertedthrough the opening of the plurality of wings.

According to one aspect, the elongated body further includes a pluralityof suture runner guides to control a location of a suture loaded ontothe template, each suture runner guide disposed at a predeterminedposition distal to an inner surface of each of the plurality of wings.

According to one aspect, the location aligns the suture in thepredetermined position to allow the suture grasper to orthogonallyintersect the suture, when the suture grasper is inserted into thesuture retrieval space.

According to one aspect, the suture grasper includes at least oneelement that can expand laterally to encircle the suture at thepredetermined position.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various embodiments consistentwith the invention, and, together with the description, serve to explainthe principles of the invention.

FIG. 1 is a perspective view of a tissue closure template, in accordancewith certain aspects of the present invention;

FIG. 2 is a perspective view of a fascial closure system showing atissue closure template and a suture grasper in a certain state of use,in accordance with certain aspects of the present disclosure;

FIG. 3 is a side view of a fascial closure system, in accordance withcertain aspects of the present disclosure;

FIG. 4 is a side perspective view of a closure template, in accordancewith certain aspects of the present disclosure;

FIG. 5 is a front view of a closure template, in accordance with otheraspects of the present disclosure;

FIG. 6 is a side view of a closure template, in accordance with certainaspects of the present disclosure;

FIG. 7 is an enlarged side view of a distal portion of a closuretemplate of FIG. 6 at A-A;

FIG. 8 is a side view of a closure template in a position of use, inaccordance with certain aspects of the present disclosure;

FIG. 9 is a side perspective view of a closure template in a position ofuse, in accordance with certain aspects of the present disclosure;

FIG. 10 is an enlarged side view of a distal portion of a closuretemplate of FIG. 9 at B-B;

FIG. 11 is a front view of a suture grasper, in accordance with certainaspects of the present disclosure in a certain state of use; and

FIG. 12 is a rear view of a suture grasper in accordance with certainaspects of the present invention.

DETAILED DESCRIPTION

The invention will now be described with reference to the drawingfigures, in which like reference numerals refer to like partsthroughout.

Various aspects of a laparoscopic fascial closure system may beillustrated by describing components that are coupled, attached, and/orjoined together. As used herein, the terms “coupled”, “attached”, and/or“joined” are used to indicate either a direct connection between twocomponents or, where appropriate, an indirect connection to one anotherthrough intervening or intermediate components. In contrast, when acomponent is referred to as being “directly coupled”, “directlyattached”, and/or “directly joined” to another component, there are nointervening elements present.

Relative terms such as “lower” or “bottom” and “upper” or “top” may beused herein to describe one element's relationship to another elementillustrated in the drawings. It will be understood that relative termsare intended to encompass different orientations of a laparoscopicfascial closure system or the components thereof in addition to theorientation depicted in the drawings. By way of example, if aspects of alaparoscopic fascial closure system shown in the drawings are turnedover, elements described as being on the “bottom” side of the otherelements would then be oriented on the “top” side of the other elements.The term “bottom” can therefore encompass both an orientation of“bottom” and “top” depending on the particular orientation of theapparatus.

Closure devices for trocar openings are used as examples of a closuredevice that can incorporate one or more of the features and derive someof the benefits described herein, and in particular closure devices forabdominal tissue openings. Closure of trocar openings in abdominal wallspresent particular issues for acceptable results, and closure devicesfor abdominal openings will be considered in more detail. However,closure devices other than for abdominal wound closures can benefit fromone or more of the present inventions.

In accordance with one example of apparatus that can be used for closinga tissue opening, for example a trocar opening in the abdominal wall,and where the apparatus reflects one or more methods that can be usedfor tissue closure, a fascial closure system 100 includes a closureassembly or closure template 102 and a needle retriever 104. The closuretemplate 102 can be used with the needle retriever 104 as discussedherein, or with other suture introducers or needles, and the needleretriever 104 as discussed herein can be used with other closuredevices. However, for purposes of some of the examples, the closuredevice 102 and the needle assembly 104 will be considered as being usedtogether. Additionally, the present discussion for the application ofthe closure assembly will be in the context of closure of an abdominalopening, but it should be understood that other tissue closures can becarried out with one or more of the components of the assembly.

In the context of a trocar opening in an abdominal wall, the openingextends through a skin and superficial layer that may include muscle,depending on the location in the abdomen at which the opening is made.The skin and superficial layer will be referred to as the skin layer forsimplicity. Underlying the skin layer is a fascial layer having a thinperitoneum. The peritoneum forms the lining of the abdominal cavityoutside the internal organs (not shown), and it is through the skinlayer, fascial layer and peritoneum that the trocar opening and trocarpermit access for an operator to the internal organs. Once the surgeryis complete, the trocar opening is closed by closing the fascial layerand peritoneal layer, while taking care to avoid puncturing or injuringany underlying organs. One way to minimize puncturing underlying organsduring the closure process is to retract the tissue layers away from theunderlying organs and to limit or carefully control the ingress ofsuture introducers or retrievers beyond the tissue wall (peritoneallayer), for example in the manner described more fully below.

As shown generally in FIGS. 1 and 2, the closure template 102 in thepresent example includes a closure body 116. The body extends from aproximal portion 118 to a distal portion 120. Generally, the proximalportion 118 is used to control and manipulate the closure device, andthe distal portion 120 forms a working structure to be inserted underthe peritoneal layer. The distal portion 120 in the present examples isused to present a portion of a preloaded suture at a known andpredetermined location where the suture can be reliably retrieved, forexample even without visualization, and in such a way that suture bitescan be made at optimal locations for forming reliable closures. Forexample, the distal portion 120 can be used as a target for inserting aretrieval tool through the fascial layer to the target for retrieving apre-disposed suture portion from the target and withdrawing the suturethrough the fascial layer and a tissue opening to help in closing theopening.

The closure template 102 also includes an intermediate or middle portion122, which will be generally considered that portion of the closure body116 residing within the laparoscopic opening during normal use. Themiddle portion 122 generally will extend between the outer surface ofthe skin layer and the peritoneal layer. The middle portion 122 includesat least one element that helps to reliably and repeatably guide aneedle retriever toward a predetermined target site without the operatorhaving to substantially adjust or vary the direction of movement of theretriever. In the present examples, as discussed more fully below, theat least one element in the middle portion 122 that helps to reliablyand repeatably place a suture introducer or retriever at thepredetermined target site is a channel or passageway, for example atrans lateral passageway 127, through the body 116 of the closure device102. In select aspects, the middle portion 122 may include a pluralityof channels or passageways extending through the body 116 of the closuredevice 102.

Considering the closure template 102 in more detail, the distal portion120 in the present example includes a plurality of wings 124, which canbe planar or curved structures that span an area wider than a suture orgrasper needle, up to a width of the closure body 116, 1102, in theembodiments shown in FIG. 1 or 5. The wings 124 form targets for asuture retriever 104. The wings 124 may extend outwardly insubstantially opposing directions from the closure body 116 in adeployed configuration as shown in FIG. 2. They are substantially 180°apart and extend substantially perpendicular to a central axis of theclosure body 116. In other examples, the closure template 102 could havea single wing or plural wings, whether arranged in pairs or otherwise.When arranged in pairs, they can be arranged in two, four, six or morepairs, as desired.

The wings 124 may be pivotally mounted to respective portions of amounting structure 126 at the distal end of the closure body 116. Thewings 124 may be linked to and operated through a pull rod 130. The pullrod 130 extends upward into and is substantially centered on the centralaxis of the closure body 116 for longitudinal movement within the body116. The pull rod 130 and wings 124 are mounted to the body 116 suchthat upward movement of the pull rod 130 pulls the link arms orexpanders upward to move the wings 124 from a collapsed or insertionconfiguration shown in FIG. 1 to the expanded or deployed configurationshown in FIG. 2. Downward movement of the pull rod 130 within the body116 fold wings 124 down relative to the body into a closed configurationor geometry capable of a traumatic insertion into the body.

In addition to the wings 124 shown in FIGS. 1 and 2, the distal portion120 may also include shield portions 132 connected to the wings 124. Theshield portions 132 are also planar or curved structures which span anarea wider than a suture or grasper needle, similar to the wings 124,and may be connected to the wings 124 by living hinges, for example, orby any suitable hinge structure such that actuation of the wings 124results in a corresponding actuation of the shield portions 132. Theshield portions 132 similarly extend from a closed position to anexpanded or deployed position when the pull rod 130 is actuated. Theshield portions 132 may also be connected at a distal end 133 and hingedto form a completely enclosed suture retrieval cavity when the wings aredeployed as shown in FIG. 2. The suture retrieval cavity provides anarea of protection to the surrounding tissues and/or internal organsfrom damage during extension of the needle retriever 104 toward thetargets to retrieve a suture portion during a suture retrievalprocedure.

FIG. 3 illustrates another laparoscopic fascial closure system 1000configured in accordance with the same general concepts as outlinedabove. The system 1000 includes a closure template 1100 for use with aneedle retriever, such as the suture grasper 200. As shown in FIGS. 3-5,the template 1100 includes an elongated body 1102 with a proximal end1104 and a distal end 1106 and a lumen 1108 provided to extendlongitudinally through the body 1102. The body 1102 may include at leastone lock feature 1109 toward the proximal end that interacts with ahandle 1110 connected to an actuator rod 1112. In one aspect, the handle1110 may include portions extending laterally from the body 1102 and/orportions extending axially from the proximal end of the body 1102. Atleast one suture needle guide lumen 1114 may traverse a central axis atan angle from the proximal portion toward the distal portion of the body1102. The needle guide lumen 1114 may include a funnel 1116 at theproximal end of the body 1102 to aid in the insertion of the needle anda needle guide exit lumen 1118 is located distal of the funnel 1116 andat predetermined distance away from top wings 1120. The top wings 1120may be connected to the body 1102 via separate living hinges or a pinhinge, for example.

In addition to the wings 1120, the distal portion of the template 1100include shields 1122 pivotally connected to the wings 1120. The shieldportions 1122 may be connected to the top wings 1120 by living hinges,for example, or by any suitable hinge structure. The shield portions1122 in turn pivotally connect to a distal tip portion 1124 of thetemplate 1100. The tip portion 1124 may be atraumatically shaped andconnected to the actuator rod 1112 such that actuation of the handle1110 results in the distal tip portion 1124 being retracted toward orextended away from the body 1102. The wings 1120 and the shield portions1122 are thus controlled by the actuation rod 1112 to extend from aclosed position to an expanded or deployed position when the actuationrod 1112 is pulled. The wings 1120 and shield portions 1122 thus form acompletely enclosed suture retrieval cavity when the wings 1120 aredeployed as shown in FIG. 8. The suture retrieval cavity provides anarea of protection to the surrounding tissues and/or internal organsfrom damage during extension of the needle retriever 104 toward thetargets to retrieve a suture portion during a suture retrievalprocedure.

The wings 1120 may be used to locate the peritoneum and allow retractionwhen expanded. Each wing 1120 may include an opening 1126, which may beround or oval or any suitable shape, that allows passage of the suturegrasper 200 into the suture retrieval cavity when the system isdeployed. Suture positioning guides and grooves are provided in the wingand may provide a predetermined position of the suture that is designedto release away from the suture when the wings are collapsed and thetemplate is retracted out of the body cavity.

Suture retaining means such as living hinge clamp and the like (notshown) may be integrated and located at the proximal portion of the bodythat may be used as an alternative design to the cleat described below.Suture clamps temporarily hold the suture in place when loaded in thedevice and may allow the suture to slide or move when the wings areactivated from a collapse to an open position.

Suture positioning guides or grooves 1130 may also be provided along thelength of the body in order to load and place a portion of a suturestrand at a predetermined position relative to the lateral wing in theopen or deployed position. The guides and grooves serve to hide thesuture by positioning it below the outer surface of the device whensuture is loaded, which may prevent inadvertent suture dislodgementduring insertion of device to the patient.

An active or passive clamping or cleating means of holding the suture inplace after loading the suture to the device may be used. For example, asuture cleat 1132 may be located toward the proximal portion of the bodyto hold the suture taut or stabilize the suture when loaded in thedevice during insertion, wing expansion and suture retrieval. The clampor cleat 1132 may allow the suture to slide or move when the lateralwings 1120 are opened and/or during suture pick-up and withdrawal usinga suture grasper and the like.

The body 1102 may include a keyway on the proximal end of the templatethat interacts with a key feature on the proximal handle of the suturegrasper device 200. The key and keyway could be configured such that thelateral expanding element is generally orthogonal to the suture to becaptured held in the template when the key resides in the keyway. Thekey/keyway feature could act as a stop and limit the penetrationdistance of the needle. The user could be instructed to bottom out thehandle of the retriever directly against the insertion point for theretriever on the template.

The shield portions 1122 are located toward the distal portion of thetemplate. As noted above, the shield portions 1122 may preventinadvertent needle perforation of organs or vessels or other tissues andmay serve as column support for the lateral wings 1120. The shieldportions 1122 may comprise at least one hinge connecting the distalshield and the top wing. The hinge configuration may comprise a pin orliving hinge or combination thereof. A living hinge may be configured tohave constant thickness at predefined length that forms a radiustransition between the top wing 1120 and the shield portion 1122. Alarger radius transition will bring the (inner surface of) the shieldfarther away from the top wing when in the open position. This in turnincreases the working space where the suture can be positioned and makeroom for the suture grasper 200 when capturing the suture.

As shown in FIG. 5, a suture guide slot 1125 may be provided at thedistal tip 1124 that keeps the suture in place. The slot 1125 provides apredetermined position of the suture and is designed to release awayfrom the suture when the template is retracted out of the body.

As shown in FIGS. 6 and 7, the actuator rod 1112 may be arrangedslidably along the body of the template connecting the distal tipportion 1124 of the device and the proximal handle 1110. When the driveris retracted proximally, the wings 1120 change from a collapsed profileto the expanded lateral position, as shown in FIGS. 8-10. The driverand/or handle 1110 can be spring loaded at the proximal end the body tobias the driver 1110 either proximally to maintain the close profile ordistally to maintain the expanded lateral position. An operator wouldovercome the spring force to either open or close the wing dependingupon the spring configuration chosen.

The side loading suture slot 1130 retains the suture 1180 duringinsertion and is configured to allow release of the suture duringretraction of the suture retriever. A suture runner guide 1140 (see alsoFIGS. 9 and 10) is provided on the body that controls the location ofthe suture at a predetermined position below the inner surface of thetop wing 1122 when the top wings are opened lateral to the body. Thelocation is configured to allow the intersection of the suture grasper200 to the suture to be aligned generally orthogonal to each other.

As shown in FIGS. 11 and 12, the suture grasper 200 may be a needle 210combined with a means to retrieve suture from the template. In oneaspect, the means to retrieve suture from the template may include atleast one grasping element 220.

The suture grasper 200 may be inserted into an insertion point on theproximal portion of the template body 1102 transverse to the centerlineof the template through an exit point of the template body 1102 throughthe soft tissue and across the aperture opening of the top wing inproximity of the suture to allow its capture and retrieval. Thisretrieval maneuver could then be repeated on the opposite side of thetemplate to facilitate retrieval of the suture there.

The suture grasper 200 may include at least one element 220 that canexpand laterally to encircle the suture 1180 and is configured to allowthe suture 1180 to slide freely after the suture has been captured. Thesuture grasper 200 may include a key feature 230 on the proximal handle240 that interacts with a keyway 1150 on the proximal end of thetemplate, as shown in FIGS. 3 and 9. In one aspect, the key feature 230may be a planar surface tapering inwards towards the needle 210, whilethe keyway 1150 may be a planar surface extending in parallel with thecentral axis of the closure body 116. In operation, the planar surfaceof the key 230 may abut the planar surface of the keyway 1150 to alignthe lateral expanding element 220 with respect to the suture. The key230 and keyway 1150 could be configured such that the lateral expandingelement 220 is generally orthogonal to the suture 1180 to be capturedheld in the template when the key 230 resides in the keyway 1150. Thekey/keyway feature could act as a stop and limit the penetrationdistance of the needle 210. The user could be instructed to bottom outthe handle 240 of the retriever directly against the insertion point forthe retriever on the template.

The suture grasper 200 may be configured to automatically activate toexpand when approaching the suture target and to deactivate or closewhen retracting the retriever thereby capturing the suture during theretraction maneuver. This would allow a surgeon to engage and removesuture using a blind technique without visualization. Theactivation/deactivation feature could work in conjunction with thekey/keyway arrangement mentioned previously.

The suture 1180 is loaded on the outside perimeter of the device withthe wings 1120 in a collapsed state, as shown in FIGS. 6 and 7, forexample, wherein the mid portion of the suture 1180 is mounted to thesuture slot 1125 at the distal tip 1124 of the device, then runs under aslot of the suture runner guides 1140 on the distal end of the body andthen continuously runs alongside the body of the device. The suture 1180is pulled taut and secured by the clamp or cleat 1132 located at theproximal portion of the device. The template 1100 may be insertedthrough a hole into the body cavity. The wings 1120 are actuated toexpand open and the device is retracted to engage the top wing 1120against the peritoneum. The suture grasper 200 may be inserted throughthe body of the template 1100, traversing the soft tissue and crossingthe aperture 1126 of the top wing to engage and capture the suturepositioned in the suture retrieval cavity. The grasper 200 is retractedout of the body cavity with the suture 1180 sliding freely at its distaltip to externalize the terminal end of the suture. The steps arerepeated on the other side of the template 1100 and then the wings 1120of the device are deactivated or closed, thereby releasing the suture1180 and then the device is retracted and removed from the body cavity.A knot is tied using the exposed ends of the suture to close the fascia.

It will be appreciated that the foregoing description provides examplesof the disclosed system and technique. However, it is contemplated thatother implementations of the disclosure may differ in detail from theforegoing examples. All references to the disclosure or examples thereofare intended to reference the particular example being discussed at thatpoint and are not intended to imply any limitation as to the scope ofthe disclosure more generally. All language of distinction anddisparagement with respect to certain features is intended to indicate alack of preference for those features, but not to exclude such from thescope of the disclosure entirely unless otherwise indicated.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context.

What is claimed is:
 1. A tissue closure device comprising: a suture; anelongated body including at least one guide lumen with an opening and anexit, the at least one guide lumen traversing the elongated body at anangle with respect to a central longitudinal axis of the elongated body;at least one proximal pivot member pivotally connected to a distalportion of the elongated body; and at least one distal pivot memberpivotally connected to the at least one proximal pivot member, wherein asuture retrieval space is defined between the at least one proximalpivot member and the at least one distal pivot member when the at leastone proximal pivot member and the at least one distal pivot member areextended away from the elongated body in a deployed position, the sutureretrieval space receiving a portion of the suture, and the at least oneproximal pivot member includes an opening to allow passage of a suturegrasper into the suture retrieval space to substantially orthogonallyintersect the portion of the suture.
 2. The tissue closure device ofclaim 1, wherein the opening is round or oval.
 3. The tissue closuredevice of claim 1, wherein the at least one distal pivot member isconnected to a corresponding one of the at least one proximal pivotmember via a living hinge.
 4. The tissue closure device of claim 1,wherein the at least one distal pivot member and the at least oneproximal pivot member are pivotally retractable to be parallel to theelongated body as the tissue closure device is moved from the deployedposition to a collapsed position.
 5. The tissue closure device of claim1, wherein the at least one distal pivot member and the at least oneproximal pivot member extend at angles laterally away from the centrallongitudinal axis when the tissue closure device is in the deployedposition.
 6. The tissue closure device of claim 1, further comprising atleast one suture runner guide configured to control a location of thesuture, wherein the at least one suture runner guide is disposed on theelongated body distal of an inner surface of the at least one proximalpivot member.
 7. The tissue closure device of claim 1, wherein thesuture grasper comprises a needle, and the at least one distal pivotmember prevent inadvertent perforation of organs, vessels, or othertissues in the deployed position.
 8. The tissue closure device of claim1, further comprising a suture cleat on a proximal portion of theelongated body configured to stabilize or hold the suture taut.
 9. Thetissue closure device of claim 1, wherein a proximal portion of theelongated body has a keyway feature configured to interact with a keyfeature on the suture grasper to orient the suture grasper with respectto the portion of the suture in the suture retrieval space.
 10. A tissueclosure system for a suturing procedure, the tissue closure systemcomprising: a suture; a suture grasper; and a tissue closure template,the tissue closure template including: an elongated body, and at leastone guide lumen with an opening and an exit, the at least one guidelumen traversing the elongated body at an angle with respect to acentral longitudinal axis of the elongated body, wherein a distalportion of the elongated body is pivotally connected to at least oneproximal pivot member that is pivotally connected to at least one distalpivot member, the at least one proximal pivot member and the at leastone distal pivot member are configured to extend laterally away from theelongated body in a deployed position, and the at least one proximalpivot member and the at least one distal pivot member define a sutureretrieval space when extended away from the elongated body in thedeployed position, the suture retrieval space receiving a portion of thesuture, and wherein the at least one proximal pivot member include anopening to allow passage of the suture grasper into the suture retrievalspace to substantially orthogonally intersect the portion of the suture.11. The tissue closure system of claim 10, wherein a distal end of thesuture grasper is insertable through the at least one guide lumen. 12.The tissue closure system of claim 10, wherein the suture graspercomprises a needle, and the at least one distal pivot member, in thedeployed position, prevent inadvertent perforation of organs, vessels,or other tissues by the suture grasper as the suture grasper is insertedthrough the opening of the at least one proximal pivot member.
 13. Thetissue closure system of claim 10, further comprising at least onesuture runner guide configured to control a location of the suture,wherein the at least one suture runner guide is disposed on theelongated body distal of an inner surface of the at least one proximalpivot member.
 14. The tissue closure system of claim 10, wherein thesuture grasper includes at least one element configured to expandlaterally to grasp the suture.
 15. A method of closing a tissue opening,the method comprising: inserting an elongated body into the opening, theelongated body including at least one guide lumen with an opening and anexit, the at least one guide lumen traversing the elongated body at anangle with respect to a central longitudinal axis of the elongated body;pivoting at least one proximal pivot member relative to a distal portionof the elongated body; pivoting at least one distal pivot memberrelative to the at least one proximal pivot member to define a sutureretrieval space between the at least one proximal pivot member and theat least one distal pivot member, the suture retrieval space receiving aportion of a suture; and inserting a suture grasper through an openingof the at least one proximal pivot member and into the suture retrievalspace to substantially orthogonally intersect the portion of the suture.16. The method of claim 15, further comprising inserting the suturegrasper through the at least one guide lumen after pivoting the at leastone proximal pivot member and the at least one distal pivot member. 17.The method of claim 15, further comprising retracting the at least onedistal pivot member and the at least one proximal pivot member to beparallel to the elongated body.
 18. The method of claim 15, wherein thesuture grasper comprises a needle, and the at least one distal pivotmember when pivoted prevent inadvertent perforation of organs, vessels,or other tissues.
 19. The method of claim 15, further comprisingcontrolling a location of the suture with at least one suture runnerguide on the elongated body.
 20. A tissue closure device comprising: asuture; an elongated body including at least one guide lumen with anopening and an exit, the at least one guide lumen traversing theelongated body at an angle with respect to a central longitudinal axisof the elongated body; at least one proximal pivot member pivotallyconnected to a distal portion of the elongated body; and at least onedistal pivot member pivotally connected to the at least one proximalpivot member; and at least one suture runner guide configured to controla location of the suture, wherein the at least one suture runner guideis disposed on the elongated body distally of an inner surface of the atleast one proximal pivot member, wherein a suture retrieval space isdefined between the at least one proximal pivot member and the at leastone distal pivot member when the at least one proximal pivot member andthe at least one distal pivot member are extended away from theelongated body in a deployed position, the suture retrieval spacereceiving a portion of the suture, and the at least one proximal pivotmember includes an opening to allow passage of a suture grasper into thesuture retrieval space to the portion of the suture.
 21. The tissueclosure device of claim 20, wherein the at least one distal pivot memberis connected to a corresponding one of the at least one proximal pivotmember via a living hinge.
 22. The tissue closure device of claim 20,wherein the at least one distal pivot member and the at least oneproximal pivot member are pivotally retractable to be parallel to theelongated body as the tissue closure device is moved from the deployedposition to a collapsed position.
 23. The tissue closure device of claim20, wherein the at least one suture runner orients the suture to allowthe suture grasper to substantially orthogonally intersect the suture,when said suture grasper is inserted into the suture retrieval space,after passing through the at least one guide lumen.
 24. A tissue closuredevice comprising: a suture; an elongated body including at least oneguide lumen with an opening and an exit, the at least one guide lumentraversing the elongated body at an angle with respect to a centrallongitudinal axis of the elongated body; a suture cleat on a proximalportion of the elongated body for stabilizing or holding the suturetaut; at least one proximal pivot member pivotally connected to a distalportion of the elongated body; and at least one distal pivot memberpivotally connected to the at least one proximal pivot member, wherein asuture retrieval space is defined between the at least one proximalpivot member and the at least one distal pivot member when the at leastone proximal pivot member and the at least one distal pivot member areextended away from the elongated body in a deployed position, the sutureretrieval space receiving a portion of the suture, and the at least oneproximal pivot member includes an opening to allow passage of a suturegrasper into the suture retrieval space to engage the portion of thesuture.
 25. The tissue closure device of claim 24, wherein the at leastone distal pivot member is connected to a corresponding one of the atleast one proximal pivot member via a living hinge.
 26. The tissueclosure device of claim 24, wherein the at least one distal pivot memberand the at least one proximal pivot member are pivotally retractable tobe parallel to the elongated body as the tissue closure device is movedfrom the deployed position to a collapsed position.